elluminate COVID-19 Analytics | Manage Risk – Minimize Impact by eClinical Solutions

Fact Sheet

COVID-19 Analytics

Manage Risk Minimize Impact

elluminate® COVID-19 Analytics help sponsors proactively manage the impact of COVID-19 on trial operations, data quality and patient safety for the duration of the pandemic. COVID-19 Analytics provide clinical trial managers and data managers with visualizations that enable them to quickly take action including those recommended in the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.1 The visualizations provide real-time information allowing trial managers to focus on those participants most likely experiencing COVID-19 related symptoms and to take actions recommended in the FDA guidance.

Monitor for Impacts Per FDA Guidance Which patients have missed visits that may require “…specific information in the case report form that explains the basis of the missing data, including the relationship to COVID-19 for missing protocol-specified information (e.g., from missed study visits or study discontinuations due to COVID-19). This information, summarized in the

clinical study report, will be helpful to the sponsor and FDA.” 1 “Trial participants [who] may not be able to come to the investigational site for protocol-specified visits,” allowing sponsors to evaluate “whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including

local labs or imaging centers) could be implemented when necessary and feasible,” 1 “Trial participants who no longer have access to investigational product or the investigational site may need additional safety monitoring (e.g. withdrawal of an active investigational treatment)...” 1

Fact sheet – COVID-19 Analytics

Study dashboards track key study timelines with visualizations such as planned vs actual

Key Benefits Mitigate COVID-19 Risk & Impact on Your Trials

Increase Oversight & Regulatory Compliance

COVID-19 visualizations indicate by country, study, and site which patients and sites are experiencing the greatest impact, including virus related symptoms and events; missed and overdue visits; missed and overdue doses; and discontinuation. Visit forecast analytics allow trial operations to put strategies and alternatives in place to help reduce future missed visits and missed dosing events. Indicator visualizations show you which patients and sites have the highest virus-related indicator scores for prioritizing mitigation efforts.

FDA Guidance references that there may be “unavoidable protocol deviations due to COVID-19 illness due to the virus.”1 Analytics allow clinical teams to focus on a subset of patients within and across trials that have the highest COVID-19 related risk factors including filtering by age, existing conditions and related symptoms like flu and fever. elluminate Analytics reduce reliance on manual processes including excel spreadsheets used to track and gather data that may be based on out-of-date data sources and need constant updating.

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Rapid Implementation Times elluminate COVID-19 Analytics are part of the elluminate SaaS platform and are complimentary for existing clients. Reports are accessed by authorized users and leverage the near real-time integrated data sources. COVID-19 Analytics are based primarily on mapped SDTM data and can be rapidly implemented. These analytics are available to new clients at a reduced rate and can be set up for use within weeks.

Fact sheet – COVID-19 Analytics

Visualizations Robust filtering to research subject populations such as those at risk based on age range and immunocompromised status. Visit and Dose Trends & Forecasts ■ Visit-related visualizations provide details on missed and overdue visits, missed and overdue doses, counts of forecasted visits by month, and the visit timelines by subject.

Visit and Dose Cumulations ■ Study level views of cumulative visits and doses. ■ Illustrate the cumulative impact of missed visits and doses over time. Pie chart indicates % expected, administered, overdue and missed doses and visits.

Missed and Forecasted Visits Cumulative

■ Filter by country, study, site, subject.

COVID Indicators ■ A broad set of terms are evaluated for reported symptoms, listed by the CDC, as indicative of COVID-19. Resultant site and participant level indicator scores provide a mechanism for prioritizing efforts.

Off Study & Disposition ■ Visualizations highlight reasons for withdrawal to assist in evaluating impact on study participant numbers.

Adverse Events ■ Displays counts of adverse events by subject and events at the level of system organ class or preferred term. ■ Filter by study, site, subject, treatment, severity.

Learn More eClinical Solutions is a leading global provider of cloud-based enterprise software and tech-enabled data services. The elluminate platform gives you greater control of your clinical data by uniting all data, regardless of source or format. Self-service access enables streamlined review and analysis, exploration, and the advanced insights to drive your biggest initiatives. elluminate and eClinical’s ASCEND clinical data services have been used by over 100 life sciences companies on more than 1000 trials.

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